RATIONALE: To improve strategies for detection and prevention of early-stage disease.

PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.

Identification and development of highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies [ Time Frame: Outcomes will be assessed at the completion of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identification of new prevention approaches and therapies [ Time Frame: Outcomes will be assessed at the completion of the study. ] [ Designated as safety issue: No ]

Identification of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer [ Time Frame: Outcomes will be assessed at the completion of the study. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Subjects blood and other specimens are collected their follow-up clinic appointments.

Women who are at increased risk of ovarian cancer based on family or personal medical history who are participating in the Northwestern Ovarian Cancer Early Detection and Prevention Program clinic.

Other: laboratory biomarker analysis

Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.

Other: screening questionnaire administration

Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.

Procedure: study of high risk factors

Subjects will be assessed for high risk factors.

Detailed Description:

OBJECTIVES:

To identify and develop highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies.

To identify new prevention approaches and therapies.

To identify measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer.

OUTLINE: Subjects undergo periodic specimen and data collection for research studies, including molecular, biochemical, functional, and genetic marker studies. Participants may have samples of blood, tissue, or body fluids (such as ascites, pleural fluid or urine), or any combination of the aforementioned samples obtained to develop tumor markers to detect early stage or recurrent ovarian cancer.

The results from the biomarker research studies will not be reported to the patient or the physician. In the future, if any of the experimental tumor markers are found to be effective in detecting early stage ovarian cancer, and the patient's result is abnormal, the patient and physician will be notified.

Subjects may be asked to complete a combination of questionnaires designed to evaluate psychological functioning among women enrolled in a comprehensive ovarian cancer early detection program who are at increased risk for developing disease as compared to women currently diagnosed with ovarian cancer.

Eligibility

Ages Eligible for Study:

18 Years to 80 Years (Adult, Senior)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Women at high risk of ovarian cancer due to family or personal medical history, or a gynecologic abnormality.

Criteria

DISEASE CHARACTERISTICS:

Meets one of the following criteria:

Considered to be at increased risk for developing ovarian cancer, as defined by one of the following:

Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer

Has at least two first or second degree relatives diagnosed before age 50 with either ovarian, primary peritoneal, fallopian tube, and/or pancreatic cancer who have tested positive for hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)or have increased risk as deemed by a certified genetic counselor

A personal or family history of a hereditary cancer syndrome that includes an increased risk of gynecologic cancer

Increased risk as deemed by a certified genetic counselor

Undergoing surgery for a gynecologic condition, including any of the following:

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005095

Locations

United States, Illinois

Robert H. Lurie Comprehensive Cancer Center at Northwestern University